Laser Treatment for the Improvement of Scars and Scleroderma

NCT04567537 | Terminated FDA Device

• 1 other identifier: 2019P002156
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma.

Conditions

Scars; Scleroderma

Keywords

Scar; Scleroderma; Laser

Outcome Measures

Primary Outcomes (6)

• Physician's Global Assessment Scale

  A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (≥90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(≥75% to \< 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (≥50% to \<75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (≥25% to \<50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - \<25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by ≥25% or more" and "Worse."

  baseline, pre-intervention

• Physician's Global Assessment Scale

  A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (≥90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(≥75% to \< 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (≥50% to \<75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (≥25% to \<50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - \<25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by ≥25% or more" and "Worse."

  1 month after baseline

• Physician's Global Assessment Scale

  A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (≥90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(≥75% to \< 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (≥50% to \<75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (≥25% to \<50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - \<25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by ≥25% or more" and "Worse."

  2 months after baseline

• Physician's Global Assessment Scale

  A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (≥90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(≥75% to \< 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (≥50% to \<75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (≥25% to \<50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - \<25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by ≥25% or more" and "Worse."

  3 months after baseline

• Physician's Global Assessment Scale

  A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (≥90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(≥75% to \< 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (≥50% to \<75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (≥25% to \<50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - \<25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by ≥25% or more" and "Worse."

  4 months after baseline

• Physician's Global Assessment Scale

  A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (≥90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(≥75% to \< 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (≥50% to \<75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (≥25% to \<50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - \<25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by ≥25% or more" and "Worse."

  Up to 1 year after baseline

Secondary Outcomes (3)

• Mouth Handicap in Systemic Sclerosis scale

  Compare baseline to post-procedural

• Vancouver Scar Scale

  Compare baseline to post-procedural

• Range of Motion Evaluation

  Compare baseline to post-procedural

Study Arms (2)

Scars

ACTIVE COMPARATOR

The entire hypertrophic scar will receive laser treatment only.

Device: Laser Treatment

Scleroderma

ACTIVE COMPARATOR

The entire lesion will receive laser treatment.

Device: Laser Treatment

Interventions

Laser Treatment DEVICE

Patients will receive three laser treatments at one-month intervals.

Scars; Scleroderma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
• In good general health, based on answers provided during the screening visit;
• Subject must be able to read and understand English;
• Any gender and any Fitzpatrick skin type;
• Age equal to or greater than 18 years old;
• Subjects in the hypertrophic scar branch must have at least one extragenital hypertrophic scar (defined as abnormal proliferation of scar tissue that forms at the site of cutaneous injury and does not regress and grows beyond the original margins of the scar) large enough to treat for both the control and experimental arm (at least 4cm in length for spit scar treatment) or two similar hypertrophic scars (at least 4cm2 for each);
• Subjects in the scleroderma branch must have eligible extragenital lesions; large enough to treat for both the control and experimental arm or two similar scleroderma areas (at least 4cm2 area for each);

You may not qualify if:

• Participation in another investigational drug or device clinical trial in the past 30 days;
• Are pregnant or lactating;
• Use of any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months;
• History of allergic reaction to topical or local anesthesia;
• Regular intake of high doses of anti-inflammatory drugs (aspirin \>81 mg/day, ibuprofen, corticosteroids, etc.) or immunosuppressive drugs;
• Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Clinical Unit for Research Trials & Outcomes in Skin

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Cicatrix; Scleroderma, Diffuse

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Dieter Manstein, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The investigators will be performing a prospective cohort study, where the entire lesion will receive laser treatment.

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 28, 2020
• Study Start: June 2, 2021
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)